Shield Therapeutics plc today announces that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for the investigational drug Feraccru (ferric maltol) capsules, a twice daily oral therapy. The data submitted in the MAA support the use of Feraccru in the treatment of adults with iron deficiency anaemia in patients with inflammatory bowel disease (IBD). The CHMP’s recommendation will now be reviewed and ratified by the European Commission, which has the authority to approve medicines for use in the twenty-eight countries of the European Union.
The company currently anticipates the product will become available on a commercial basis during the first half of 2016.
This positive opinion is based on data from the company’s prospective, randomised, placebo controlled “AEGISBack to news